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Trial record 31 of 331 for:    DONEPEZIL

Computerized Cognition Testing in Participants With Mild Alzheimer's Disease (AD) Treated With Donepezil (MK-0000-318)

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ClinicalTrials.gov Identifier: NCT02064920
Recruitment Status : Completed
First Posted : February 17, 2014
Results First Posted : August 1, 2017
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Diagnostic
Condition Alzheimer's Disease
Interventions Drug: Placebo
Drug: Donepezil
Enrollment 36
Recruitment Details Males and females with mild Alzheimer's Disease (AD) between the ages of 55 and 85 years (inclusive) were enrolled in this trial.
Pre-assignment Details  
Arm/Group Title Placebo Donepezil
Hide Arm/Group Description Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks. During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
Period Title: Overall Study
Started 6 30
Treated 6 28 [1]
Completed 5 21
Not Completed 1 9
Reason Not Completed
Adverse Event             0             4
Physician Decision             0             1
Technical Problems             0             1
Withdrawal by Subject             1             3
[1]
Two participants discontinued from study prior to treatment
Arm/Group Title Placebo Donepezil Total
Hide Arm/Group Description Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks. During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability. Total of all reporting groups
Overall Number of Baseline Participants 6 30 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 30 participants 36 participants
76.7  (8.6) 72.7  (8.7) 73.4  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 30 participants 36 participants
Female
2
  33.3%
15
  50.0%
17
  47.2%
Male
4
  66.7%
15
  50.0%
19
  52.8%
1.Primary Outcome
Title One-card Learning (OCL) Measurement Over 12 Weeks of Treatment
Hide Description OCL is one of the Cogstate battery of tests, and is a continuous visual recognition task that assesses visual recognition, memory and attention using a pattern separation algorithm. OCL is a score defined as the arcsine transformation of the square root of the proportion of correct responses to 80 OCL questions. The score ranges from 0 to 1.5708 where a higher score means better performance.
Time Frame Weeks 4, 8, 12 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study medication and yielded at least one measurement for that endpoint.
Arm/Group Title Placebo Donepezil
Hide Arm/Group Description:
Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
Overall Number of Participants Analyzed 5 28
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Week 4 (n = 5, 28) 0.954  (0.091) 0.942  (0.112)
Week 8 (n = 5, 22) 0.822  (0.179) 0.969  (0.104)
Week 12 (n = 5, 21) 0.849  (0.132) 0.984  (0.118)
Week 16 (n = 5, 21) 0.961  (0.123) 0.993  (0.112)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Donepezil
Comments Change from Week 4 to Week 16 in Standard Deviation (SD) of OCL for Placebo + Donezepil treatment groups combined
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Change in SD from Week 4 to Week 16
Estimated Value 0.005
Confidence Interval (2-Sided) 95%
-0.031 to 0.039
Estimation Comments SD of average OCL repeated measurements after 12 weeks of treatment for Placebo + Donezepil treatment groups combined is hypothesized to be ≤ 0.1.
2.Secondary Outcome
Title Percentage of Correct Responses in the OCL Task Over 12 Weeks of Treatment
Hide Description OCL is one of the Cogstate battery of tests, and is a continuous visual recognition task that assesses visual recognition, memory and attention using a pattern separation algorithm. The percentage of correct responses to 80 OCL questions is defined as the number of correct responses x 100 divided by the number of total responses; and ranges from 0 to 100, where 100 is best, and 0 is the worst outcome.
Time Frame Weeks 4, 8, 12 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study medication and yielded at least one measurement for that endpoint.
Arm/Group Title Placebo Donepezil
Hide Arm/Group Description:
Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
Overall Number of Participants Analyzed 5 28
Mean (Standard Deviation)
Unit of Measure: Percentage of Corrrect Responses
Week 4 (n = 5, 28) 66.2  (8.3) 64.9  (10.3)
Week 8 (n = 5, 22) 53.7  (17.1) 67.4  (9.5)
Week 12 (n = 5, 21) 56.1  (12.7) 68.6  (10.4)
Week 16 (n = 5, 21) 66.7  (11.6) 69.5  (9.8)
Time Frame Up to Week 18 (approximately up to 129 days)
Adverse Event Reporting Description All participants who received study medication.
 
Arm/Group Title Placebo Donepezil
Hide Arm/Group Description Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks. During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
All-Cause Mortality
Placebo Donepezil
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Donepezil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      1/28 (3.57%)    
General disorders     
Chest pain  1  0/6 (0.00%)  0 1/28 (3.57%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Donepezil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/6 (50.00%)      9/28 (32.14%)    
Gastrointestinal disorders     
Diarrhoea  1  1/6 (16.67%)  1 4/28 (14.29%)  4
Infections and infestations     
Nasopharyngitis  1  1/6 (16.67%)  1 0/28 (0.00%)  0
Investigations     
Blood urea increased  1  1/6 (16.67%)  1 0/28 (0.00%)  0
Nervous system disorders     
Dizziness  1  0/6 (0.00%)  0 2/28 (7.14%)  2
Headache  1  1/6 (16.67%)  1 2/28 (7.14%)  2
Psychiatric disorders     
Insomnia  1  0/6 (0.00%)  0 2/28 (7.14%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02064920     History of Changes
Other Study ID Numbers: 0000-318
First Submitted: February 14, 2014
First Posted: February 17, 2014
Results First Submitted: July 5, 2017
Results First Posted: August 1, 2017
Last Update Posted: October 12, 2018